Cook TPNRecalls & reported problems across all models

We found 17 models of Cook TPN by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 173 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2014 and Aug 23, 2022 — classified as 75 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Break” (65 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Cook TPN problems

Cook TPN models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cook TPN G04261

  Catheter,intravascular,therapeutic,short-term less than 30 days
  30 reports
• Cook TPN G07903

  Catheter,intravascular,therapeutic,short-term less than 30 days
  29 reports
• Cook TPN G07902

  Catheter,intravascular,therapeutic,short-term less than 30 days
  25 reports
• Cook TPN G07933

  Catheter,intravascular,therapeutic,short-term less than 30 days
  16 reports
• Cook TPN G03319

  Catheter,intravascular,therapeutic,short-term less than 30 days
  12 reports
• Cook TPN G07935

  Catheter,intravascular,therapeutic,short-term less than 30 days
  12 reports
• Cook TPN G07960

  Catheter,intravascular,therapeutic,short-term less than 30 days
  9 reports
• Cook TPN G01868

  CATHETER, PERCUTANEOUS
  7 reports
• Cook TPN G01880

  Catheter,intravascular,therapeutic,short-term less than 30 days
  7 reports
• Cook TPN G02120

  CATHETER, PERCUTANEOUS
  7 reports
• Cook TPN G01873

  Catheter,intravascular,therapeutic,short-term less than 30 days
  6 reports
• Cook TPN G29464

  Catheter,intravascular,therapeutic,short-term less than 30 days
  5 reports
• Cook TPN G01869

  CATHETER, PERCUTANEOUS
  4 reports
• Cook TPN G01872

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook TPN G08074

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook TPN G12022

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• Cook TPN G32440

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report

Recent Cook TPN adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD A TRANSLUMBAR TUNNELED CENTRAL VENOUS CATHETER (CVC) THAT REQUIRED REPAIR ON (B)(6) 2020. A REPAIR WAS COMPLETED WITH A COOK TPN SINGLE LUMEN CATHETER REPAIR SET (RPN: C-RHCS-6.5, LOT NUMBER 9836148). TWO YEARS LATER, THE SAME CVC REQUIRED ANOTHER REPAIR AT THE SAME LOCATION. DURING THE REPAIR, IT WAS NOTED THAT THE METAL ROD OF THE PREVIOUS REPAIR KIT HAD MIGRATED TOWARDS THE INSERTION POINT OF THE CATHETER AND WAS LOCATED AT THE AREA WHERE THE CVC SECUREMENT DEVICE HAD BEEN PLACED. THE METAL ROD WAS THEN PUSHED BACK TOWARDS THE CATHETER HUB BEFORE THE LUMEN WAS CUT FOR REPAIR. THE LUMEN WAS REPAIRED WITH ANOTHER COOK TPN SINGLE LUMEN CATHETER REPAIR SET, (RPN: C-RHCS-6.5, LOT NUMBER 9836148). THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15276329 ↗
• InjuryAug 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286877 ↗
• InjuryJul 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143352 ↗
• InjuryJun 11, 2021Crack; Crack

  IT WAS REPORTED A MALE PATIENT REQUIRED A REDO DOUBLE LUMEN TPN CATHETER SET FOR AN UNKNOWN PROCEDURE. SOME TIME AFTER THE PROCEDURE, THE DEVICE WAS NOTED TO HAVE CRACKED. AN ADDITIONAL SURGERY WAS REQUIRED FOR THE "CONSTRUCTION" OF A NEW DEVICE ON THE LEFT SIDE OF THE PATIENT. THE PATIENT REPORTEDLY "SUFFERED FROM REQUIRED INPATIENT CARE AND PSYCHOSOCIAL STRESS". ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Distress; Scar Tissue

  MAUDE report 11983790 ↗
• InjuryFeb 9, 2021Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 19FEB2021, IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT JUGULAR VEIN FOR PARENTERAL NUTRITION IN WHICH INFUSIONS OF TRAVASOL AND LIPIDS WERE BEING ADMINISTERED. THE DEVICE WAS SECURED TO THE PATIENT WITH THE SPECIALIZED DRESSING TEGADERM ADVANCE. THERE WAS NO DIFFICULTY ATTACHING OR DISCONNECTING ANCILLARY DEVICES SUCH AS EXTENSION WITH NEEDLELESS CONNECTORS AND DELIVERY TUBING TO THE CATHETER. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "QUITE RESTLESS." THE DEVICE FAILED DURING HYPERALIMENTATION TREATMENT. THE FIRST BREAK OCCURRED AT HOME WHERE THE CATHETER WAS HELD IN PLACE WITH KITE LOCK. THE SECOND BREAK HAD A CONTINUOUS INFUSION OF SOLUTE. THERE WAS A NEED FOR RELOCATION OF ANOTHER CENTRAL LINE. THE PATIENT WAS HOSPITALIZED OR REQUIRED PROLONGED HOSPITALIZATION. THE DEVICE IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11301124 ↗
• InjuryFeb 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 19FEB2021, IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT JUGULAR VEIN FOR PARENTERAL NUTRITION IN WHICH INFUSIONS OF TRAVASOL AND LIPIDS WERE BEING ADMINISTERED. THE DEVICE WAS SECURED TO THE PATIENT WITH THE SPECIALIZED DRESSING TEGADERM ADVANCE. THERE WAS NO DIFFICULTY ATTACHING OR DISCONNECTING ANCILLARY DEVICES SUCH AS EXTENSION WITH NEEDLELESS CONNECTORS AND DELIVERY TUBING TO THE CATHETER. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "QUITE RESTLESS." THE DEVICE FAILED DURING HYPERALIMENTATION TREATMENT. THE FIRST BREAK OCCURRED AT HOME WHERE THE CATHETER WAS HELD IN PLACE WITH KITE LOCK. THE SECOND BREAK HAD A CONTINUOUS INFUSION OF SOLUTE. THERE WAS A NEED FOR RELOCATION OF ANOTHER CENTRAL LINE. THE PATIENT WAS HOSPITALIZED OR REQUIRED PROLONGED HOSPITALIZATION. THE DEVICE IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11300867 ↗
• InjuryDec 3, 2020Material Separation; Material Separation

  IN THE DEVICE FAILURE ANALYSIS SIGNED ON (B)(6) 2021, IT WAS FOUND THAT THE RED HUB PLUNGER WOULD NOT RELEASE FLUID. ENCRUSTATION WAS NOTED ON THE DEVICE. WHILE FLUID WAS ABLE TO EXIT THE DISTAL TIP OF THE BLUE HUB, A LOT OF RESISTANCE WAS NOTED IN DOING SO.

  Patient problems: No Code Available

  MAUDE report 10941399 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITIONAL INFORMATION RECEIVED ON 25NOV2020, IT WAS REPORTED THAT ANTIBIOTICS WERE USED TO TREAT THE OCCURRENCE OF SEPSIS. THE ONLY PRE-EXISTING CONDITION THAT WOULD HAVE MADE THE PATIENT PRE-DISPOSED FOR TO A HIGHER RISK OF INFECTION WAS SHORT BOWEL SYNDROME. THE PATIENT WAS DESCRIBED AS SELF CARING AT THE TIME SEPSIS OCCURRED. THE DEVICE WAS PLACED IN THE LEFT INTERNAL JUGULAR FOR TPN ADMINISTRATION. THE FAILURE OCCURRED DURING TREATMENT. WHEN NOT IN USE, THE CATHETER WAS FLUSHED WITH AND LOCKED AN 0.9% SALINE SOLUTION. A PRESUMED 10ML SYRINGE WAS USED FOR FLUSHING. A NEEDLELESS INJECTOR CAP WAS USED, HOWEVER NO ANTI-TAMPER DEVICE WAS USED. THE DEVICE WAS INITIALLY SECURED WITH SUTURES, HOWEVER GRIPLOK WAS LATER USED. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "ACTIVE."

  Patient problems: No Code Available; Sepsis

  MAUDE report 10868375 ↗
• InjuryNov 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A REDO SINGLE LUMEN TPN CATHETER HAS SPLIT. THE PATIENT HAS REPORTEDLY GONE THROUGH "SEVERAL" LINES AND HAS PRESENTED WITH A SPLIT LINE TWICE IN (B)(6) 2020. THE SECOND SPLIT IS ALSO REPORTED UNDER AN MDR WITH PATIENT IDENTIFIER (B)(6). DUE TO THIS OCCURRENCE, IT WAS REPORTED THE PATIENT REQUIRED "MORE VENOUS INTERVENTION" AND X-RAY IMAGING. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10786389 ↗
• InjuryJul 16, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10284116 ↗
• InjuryJul 10, 2020Break; Break

  IT WAS REPORTED THAT A COOK TPN TRIPLE LUMEN TPN CATHETER SET WAS FOUND TO BE BROKEN AND LEAKING. THE DEVICE WAS PLACED IN THE JUGULARIS INTERNA RIGHT ON (B)(6) 2020 AND SECURED TO THE PATIENT USING SUTURES AND A BANDAGE. WHEN NOT IN USE, THE CATHETER WAS MAINTAINED WITH A HEPARIN LOCK. THE PATIENT WAS REPORTED TO BE BEDRIDDEN. DATE OF EVENT WAS ORIGINALLY REPORTED AS (B)(6) 2020. ADDITIONAL INFORMATION WAS RECEIVED STATING ON 03JUN2020, THE NURSE NOTICED THAT THE BED WAS WET WHERE THE THREE LUMENS OF THE CENTRAL VENOUS CATHETER WERE LOCATED. IT WAS NOTED THAT THE CATHETER HAD BEEN "PIERCED" JUST BEFORE THE CATHETER DIVIDED INTO THREE LUMENS. THE DEVICE HAD BEEN INDWELLING FOR 8 WEEKS. NO PROBLEMS WITH FLUSHING OR DRAWING FLUIDS FROM THE CATHETER HAD BEEN NOTICED. THE CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED UNDER FULL ANESTHESIA. ABOUT SIX HOURS POST-PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO SEPSIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SPENT TWO AND A HALF WEEKS IN THE ICU. THE PATIENT STILL HAS INPATIENT STATUS.

  Patient problems: No Code Available; Sepsis

  MAUDE report 10260325 ↗
• MalfunctionJul 10, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 17JUL2020. IT WAS REPORTED THE CATHETER WAS FIRST PLACED ON "30DEC2020" IN THE PATIENT'S THORAX. IT IS LIKELY THE CATHETER WAS ACTUALLY PLACED ON 30DEC2019. IT WAS REPAIRED ONCE ON (B)(6) 2020 AND AGAIN ON (B)(6) 2020. AFTER EACH REPAIR THE PATIENT WAS HOSPITALIZED AS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259967 ↗
• InjuryJul 10, 2020Break; Break

  NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 10259751 ↗
• InjuryJul 10, 2020Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A COOK TPN TRIPLE LUMEN TPN CATHETER SET WAS FOUND TO BE BROKEN AND LEAKING. THE DEVICE WAS PLACED IN THE JUGULARIS INTERNA RIGHT AND SECURED TO THE PATIENT USING SUTURES AND A BANDAGE. WHEN NOT IN USE, THE CATHETER WAS MAINTAINED WITH A HEPARIN LOCK. THE PATIENT WAS REPORTED TO BE ACTIVE. ON (B)(6) 2020, WHILE FLUSHING THE DEVICE, BLOOD WAS FOUND TO BE SLOWLY SEEPING OUT OF THE CATHETER, JUST BEFORE IT SPLITS INTO THREE LUMENS. NO OTHER PROBLEMS WERE NOTED WITH FLUSHING OR DRAWING FLUIDS. THE DEVICE HAD BEEN INDWELLING FOR 8 WEEKS. THE CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED UNDER FULL ANESTHESIA. NO COMPLICATIONS WERE NOTED DURING THE REPLACEMENT PROCEDURE. THE PATIENT NOW HAS OUTPATIENT STATUS.

  Patient problems: No Code Available

  MAUDE report 10259154 ↗
• MalfunctionMay 12, 2020Break; Fitting Problem; Break; Fitting Problem

  A DEVICE FAILURE ANALYSIS WAS CONDUCTED ON 01JUN2020 FOR THE RETURNED DEVICE AND FOUND THAT IN ADDITION TO THE BREAK IN THE LINE, THE SILICONE SLEEVE HAS COME LOOSE FROM THE WINGED HUB, WHICH WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10048335 ↗

Other Cook Incorporated products

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